BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE DEPTH GAUGE

    MDR report key: 4110667 · Received September 16, 2014

    Report

    Report Number
    9614497-2014-00154
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    May 14, 2016
    Manufacturer
    GREATBATCH MEDICAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS CURRENTLY IN PROCESS. ONCE COMPLETED A FOLLOW UP MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE NAME WAS CORRECTED TO "FLEXIBLE DEPTH GAUGE".

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS NOT CONFIRMED AS THE COMPLAINT SAMPLE WAS NOT RETURNED FROM THE CUSTOMER FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENT MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    GREATBATCH MEDICAL IS NOT THE LEGAL MANUFACTURER OF THE DEVICE INVOLVED IN THIS INCIDENT.

    Description of Event or Problem · 1

    THE USER FACILITY RAISED A CONCERN REGARDING THE ABILITY TO CLEAN THE FLEXIBLE DRILL SHAFT DUE TO THE COILED DESIGN OF THE INSTRUMENT, AND THE LIKELIHOOD OF CONTAMINANTS BECOMING TRAPPED WITHIN THE COILS DURING USE AND SUBSEQUENTLY BEING TRANSFERRED TO THE PT, WITH POSSIBLE INFECTION RISK. AS A RESULT IT RAISES CONCERNS FOR THE PROCESSING OF THE FLEXIBLE DEPTH GAUGE. AS OF THE DATE OF THIS REPORT THERE HAVE BEEN NO CONFIRMED REPORTS OF PT INFECTION AS A RESULT OF SIMILAR INCIDENTS.

    Description of Event or Problem · 1

    THE USER FACILITY RAISED A CONCERN REGARDING THE ABILITY TO CLEAN THE FLEXIBLE DEPTH GAUGE DUE TO THE COILED DESIGN OF THE INSTRUMENT, AND THE LIKELIHOOD OF CONTAMINANTS BECOMING TRAPPED WITHIN THE COILS DURING USE AND SUBSEQUENTLY BEING TRANSFERRED TO THE PATIENT, WITH POSSIBLE INFECTION RISK. AS A RESULT IT RAISES CONCERNS FOR THE PROCESSING OF THE FLEXIBLE DEPTH GAUGE. AS OF THE DATE OF THIS REPORT THERE HAVE BEEN NO CONFIRMED REPORTS OF PATIENT INFECTION AS A RESULT OF SIMILAR INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571745 FLEXIBLE DEPTH GAUGE FLEXIBLE DEPTH GAUGE LXH GREATBATCH MEDICAL SA 31-100597 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1